EVALUATE YOUR GOUT PATIENTS USING:
Graphic spelling out the word 'STOP,' with the letter 'O' represented as a stop sign with a hand in the center Graphic spelling out the word 'STOP,' with the letter 'O' represented as a stop sign with a hand in the center Graphic spelling out the word 'STOP,' with the letter 'O' represented as a stop sign with a hand in the center
IF THEIR GOUT IS UNCONTROLLED

It’s time for KRYSTEXXA

Learn More

sUA, serum uric acid; ULT, urate-lowering therapy.

DISEASE STATE

Stop Icon is based on the 2020 ACR Guidelines, which STRONGLY RECOMMEND pegloticase for your patients with uncontrolled gout1,2

ACR, American College of Rheumatology; sUA, serum uric acid; ULT, urate-lowering therapy.

Graphic explaining that KRYSTEXXA is for patients who fail to reach sUA target on maximum dosage of ULTs (allopurinol or febuxostat) and have at least one of the following: frequent flares (2 or more flares per year) or nonresolving tophiGraphic explaining that KRYSTEXXA is for patients who fail to reach sUA target on maximum dosage of ULTs (allopurinol or febuxostat) and have at least one of the following: frequent flares (2 or more flares per year) or nonresolving tophi

Stop Banner

Stop Banner

KRYSTEXXA is not indicated for the treatment of pain and has not been studied to reverse damage to the heart, kidneys, or any organ.

Regularly checking sUA levels and assessing symptoms are the first steps to getting gout back under control.

PATIENT PROFILE

Meet Susan:

a patient with uncontrolled gout you may see in your practice

Susan, patient profile

Patient Name:
Susan

Age:
45

Occupation:
Dental hygienist

Patient history icon

Patient History

Patient history icon
  • CKD stage 3b
  • Diagnosed with gout 3 years ago by a primary care physician
  • Flares: 3 flares in the last year; complaining of joint pain
  • Tophi: 1 small tophus on her left hand for the past 2 years
  • Comorbidities: hypertension, diabetes
Patient background icon

Patient Background

Patient background icon
  • An increase in gout flares has kept her from participating in school and community activities with her 3 children
  • Her joint pain makes it difficult to use certain tools and perform the fine motor skills needed to do her job effectively. She worries it may lead to permanent disability
  • Some patients have asked about the bump on her hand, making her feel self-conscious and causing anxiety
Treatment history icon

Current Treatments

Allopurinol:

300 mg QD

Losartan:

50 mg QD

Metformin:

850 mg QD

Physical and lab evaluation icon

Laboratory Workup

sUA level:

7.9 mg/dL

G6PD:

normal

Albuminuria:

200 mg/g

eGFR:

41 mL/min/1.73 m2

BP:

130/82 mm Hg

Gout flare medication icon

Flare Medication

Colchicine:

0.6 mg

Prednisone:

40 mg

KRYSTEXXA is not indicated for the treatment of pain.

CKD, chronic kidney disease; eGFR, estimated glomerular filtration rate; G6PD, glucose-6-phosphate dehydrogenase; sUA; serum uric acid; QD, every day.

Actor portrayal, not actual patient.

Uncontrolled gout puts your CKD patients at risk. STOP and evaluate if they’re ready for KRYSTEXXA.

Learn about other patients with uncontrolled gout. Patient Profiles

EFFICACY

PRIMARY ENDPOINT

Patient relative response improved by >80% using KRYSTEXXA with methotrexate at Month 61*†

Complete sUA responders

The primary efficacy endpoint was the proportion of responders.1*† In the pivotal clinical trials for KRYSTEXXA, 42% of patients had sUA response and met the primary endpoint of maintaining sUA <6 mg/dL for ≥80% of the time in Month 3 and Month 6 (n=36/85).1,13

*Defined by patients achieving and maintaining sUA <6 mg/dL for at least 80% of the time during Month 6.1

†MIRROR RCT was a 52-week, randomized double-blind trial conducted in adult patients with chronic gout refractory to conventional therapy to evaluate administration of KRYSTEXXA 8 mg Q2W co-administered with 15 mg oral methotrexate QW and 1 mg oral folic acid QD vs KRYSTEXXA alone.1,14

MIRROR, Methotrexate to Increase Response Rates in Patients with Uncontrolled Gout Receiving Pegloticase; RCT, randomized controlled trial; QD, every day; QW, every week; Q2W, every 2 weeks.

KRYSTEXXA with methotrexate1

KRYSTEXXA alone1

Pie chart showing responders of KRYSTEXXA with methotrexate in Month 6, with 71% (n=71/100) achieving the primary endpoint

vs

Pie chart showing responders of KRYSTEXXA alone in Month 6, with 39% (n=20/52) achieving the primary endpoint

n=71/100

P<0.0001

n=20/52

SECONDARY ENDPOINT

KRYSTEXXA with methotrexate provided 94% relative improvement in patient response at Month 121

Complete sUA responders

The secondary efficacy endpoint was the proportion of responders.1*†‡

*Defined by patients achieving and maintaining sUA <6 mg/dL for at least 80% of the time during Month 12.1

†In the pivotal clinical trials for KRYSTEXXA, 42% of patients had sUA response and met the primary endpoint of maintaining sUA <6 mg/dL for ≥80% of the time in Month 3 and Month 6 (n=36/85).1,13

‡MIRROR RCT was a 52-week, randomized double-blind trial conducted in adult patients with chronic gout refractory to conventional therapy to evaluate administration of KRYSTEXXA 8 mg Q2W co-administered with 15 mg oral methotrexate QW and 1 mg oral folic acid QD vs KRYSTEXXA alone.1,14

MIRROR, Methotrexate to Increase Response Rates in Patients with Uncontrolled Gout Receiving Pegloticase; RCT, randomized controlled trial; QD, every day; QW, every week; Q2W, every 2 weeks.

KRYSTEXXA with methotrexate1

KRYSTEXXA alone1

Pie chart showing responders of KRYSTEXXA with methotrexate in Month 12, with 60% (n=60/100) achieving the secondary endpoint

vs

Pie chart showing responders of KRYSTEXXA alone in Month 12, with 31% (n=16/52) achieving the secondary endpoint

n=60/100

P=0.0003

n=16/52

*Defined by patients achieving and maintaining sUA <6 mg/dL for at least 80% of the time during Month 12.1

†In the pivotal clinical trials for KRYSTEXXA, 42% of patients had sUA response and met the primary endpoint of maintaining sUA <6 mg/dL for ≥80% of the time in Month 3 and Month 6 (n=36/85).1,13

‡MIRROR RCT was a 52-week, randomized double-blind trial conducted in adult patients with chronic gout refractory to conventional therapy to evaluate administration of KRYSTEXXA 8 mg Q2W co-administered with 15 mg oral methotrexate QW and 1 mg oral folic acid QD vs KRYSTEXXA alone.1,14

MIRROR, Methotrexate to Increase Response Rates in Patients with Uncontrolled Gout Receiving Pegloticase; RCT, randomized controlled trial; QD, every day; QW, every week; Q2W, every 2 weeks.

SAFETY
ADVERSE REACTIONS

KRYSTEXXA with methotrexate demonstrated an 87% relative reduction in infusion reactions1

87%

*Adverse reactions occurring in 5% or more of patients in either the KRYSTEXXA with methotrexate or KRYSTEXXA alone study arm during a 12-month period.1

†Mobilization flares at the beginning of treatment can be a sign KRYSTEXXA is working.1

‡Included one case of anaphylaxis.1

MIRROR RCT most common adverse reactions1*

No new safety signals observed.

*Adverse reactions occurring in 5% or more of patients in either the KRYSTEXXA with methotrexate or KRYSTEXXA alone study arm during a 12-month period.1

†Mobilization flares at the beginning of treatment can be a sign KRYSTEXXA is working.1

‡Included one case of anaphylaxis.1

MIRROR, Methotrexate to Increase Response Rates in Patients with Uncontrolled Gout Receiving Pegloticase; MTX, methotrexate; RCT, randomized controlled trial.

Watch Now

Learn more about the risks of uncontrolled gout and how one nephrologist used KRYSTEXXA with methotrexate to help bring the disease back under control.

Bhavnish Bucktowarsing video preview
View transcript

Okay, and here we go.

My name is Bhavnish Bucktowarsing and I’m a nephrologist in Canton, Ohio. I take care of patients with chronic kidney disease, hypertension and other chronic illnesses.

Gout is recognized mostly as a rheumatological issue, a joint issue, but if you look at it at its core, it’s more of a metabolic disease. People say hypertension and diabetes are silent killers, but you could probably put gout in that domain as well. Once you reach stage 3 kidney disease, your kidney is not doing well, you’re not filtering uric acid. Uric acid goes up, then that causes systemic inflammation. The most common thing I see, is the moment you have uncontrolled gout, those patients tend to have cardiac disease. They have of course chronic kidney disease. I would say a third to even more than that of my patients will have elevated uric acid when I first start seeing them. That’s where the conversation starts about how having a high uric acid level can aggravate those other risk factors around your kidneys. And it really is an eye opener for a lot of patients, they don’t realize it. When it comes to speed of resolution of gout it is very important because you’re in a constant state of systemic uric acid deposition. So, that itself means you’re chronically inflamed and the longer you let that process brew, the longer you’re at risk of having more and more complications from high uric acid levels.

I think the first patient I had was already on 300mg allopurinol, he was flaring twice a year or even more and he had a uric acid of 9.5 when I saw him in the office. And he was miserable. Of course he was seeing me for his kidneys, but every time he would come to me, he would complain about his joints, how they were hurting. This patient, he lived on a farm, he had to be active. Unfortunately, gout was preventing him from doing that. We talked about his joint mobility and how we can try to improve that with KRYSTEXXA infusion. As with many biologic therapies there is a risk of anaphylaxis and infusion reactions. After 2 or 3 months, he was feeling so much better, and he had a smile on his face after a while. I want the best outcome possible, so, I tell them that we’re going to shoot for a treatment time of a year. Really not that much of a time if you think that you’re going to be my patient moving forward pretty much for the rest of your life. Now that he’s finished treatment, it was a just a blip in time, as compared to the entire lifespan that I’m going to be seeing him for. He was able to walk around without having to take pain medications anymore and he was getting back to his activities on the farm.

Well, I think if you look at the studies, especially Mirror RCT, there was an almost 80 – 90% relative improvement in efficacy when you give it with immunomodulation as compared with no immunomodulation, so I talk to them about methotrexate and my regimen would be starting them at 15mg once a week about 4 weeks prior to the first infusion. At 15mg once a week, you’re looking at just enough immunomodulation to control their immune system but it’s not enough to cause other negative side effects on their kidneys. We’re giving them that just so they can tolerate the drug and have better outcomes. So that really made me comfortable prescribing methotrexate.

There’s a lot of aspects that we take care of as nephrologists, and I think that part of that means controlling gout. If you think about having a patient with kidney disease and their uric acid is elevated, it becomes the responsibility of the nephrologist to try to control that gout because the kidneys are not doing what they should be doing. Given the effects that has on other chronic illnesses, it should definitely be within our arsenal of things we can do for our patients to help them get better.

I’m Dr. Bhavnish Bucktowarsing, I’m a nephrologist and these are our patients.

The risk of systemic inflammation

In this exclusive new video, Dr Bhavnish Bucktowarsing, board-certified nephrologist, shares his perspective on gout as a silent killer and the risks of systemic inflammation as well as his experience prescribing KRYSTEXXA with methotrexate.

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Yes

I treat patients with KRYSTEXXA.

We appreciate the important part you play in your patients’ treatment of uncontrolled gout.

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patients and practice.

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But I would like to learn how.

Thank you for taking the first step in helping patients on their unique uncontrolled gout journey. To get your patients started on KRYSTEXXA, contact a Horizon Representative now.

A Horizon Representative will guide you every step of the way.

Questions or support? See more data below or connect with someone in your area.

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Full Important Safety Information

IMPORTANT SAFETY INFORMATION

WARNING: ANAPHYLAXIS AND INFUSION REACTIONS, G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA

  • Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA.
  • Anaphylaxis may occur with any infusion, including a first infusion, and generally manifests within 2 hours of the infusion. Delayed hypersensitivity reactions have also been reported.
  • KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions.
  • Premedicate with antihistamines and corticosteroids and closely monitor for anaphylaxis for an appropriate period after administration of KRYSTEXXA.
  • Monitor serum uric acid levels prior to each infusion and discontinue treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.
  • Screen patients at risk for glucose-6-phosphate dehydrogenase (G6PD) deficiency prior to starting KRYSTEXXA. Hemolysis and methemoglobinemia have been reported with KRYSTEXXA in patients with G6PD deficiency. KRYSTEXXA is contraindicated in patients with G6PD deficiency.

CONTRAINDICATIONS:

  • In patients with G6PD deficiency.
  • In patients with history of serious hypersensitivity reactions, including anaphylaxis, to KRYSTEXXA or any of its components.

WARNINGS AND PRECAUTIONS

Gout Flares: An increase in gout flares is frequently observed upon initiation of anti-hyperuricemic therapy, including KRYSTEXXA. Gout flare prophylaxis with a non-steroidal anti-inflammatory drug (NSAID) or colchicine is recommended starting at least 1 week before initiation of KRYSTEXXA therapy and lasting at least 6 months, unless medically contraindicated or not tolerated.

Congestive Heart Failure: KRYSTEXXA has not been formally studied in patients with congestive heart failure, but some patients in the pre-marketing placebo-controlled clinical trials experienced exacerbation. Exercise caution in patients who have congestive heart failure and monitor patients closely following infusion.

ADVERSE REACTIONS

The most commonly reported adverse reactions (≥5%) are:

KRYSTEXXA co-administration with methotrexate trial:

KRYSTEXXA with methotrexate: gout flares, arthralgia, COVID-19, nausea, and fatigue; KRYSTEXXA alone: gout flares, arthralgia, COVID-19, nausea, fatigue, infusion reaction, pain in extremity, hypertension, and vomiting.

KRYSTEXXA pre-marketing placebo-controlled trials:

gout flares, infusion reactions, nausea, contusion or ecchymosis, nasopharyngitis, constipation, chest pain, anaphylaxis, and vomiting.

INDICATION

KRYSTEXXA® (pegloticase) is indicated for the treatment of chronic gout in adult patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.

Limitations of Use: KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.

Please see Full Prescribing Information, including Boxed Warning.

Full Important Safety Information

IMPORTANT SAFETY INFORMATION

WARNING: ANAPHYLAXIS AND INFUSION REACTIONS, G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA

  • Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA.
  • Anaphylaxis may occur with any infusion, including a first infusion, and generally manifests within 2 hours of the infusion. Delayed hypersensitivity reactions have also been reported.
  • KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions.
  • Premedicate with antihistamines and corticosteroids and closely monitor for anaphylaxis for an appropriate period after administration of KRYSTEXXA.
  • Monitor serum uric acid levels prior to each infusion and discontinue treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.
  • Screen patients at risk for glucose-6-phosphate dehydrogenase (G6PD) deficiency prior to starting KRYSTEXXA. Hemolysis and methemoglobinemia have been reported with KRYSTEXXA in patients with G6PD deficiency. KRYSTEXXA is contraindicated in patients with G6PD deficiency.

CONTRAINDICATIONS:

  • In patients with G6PD deficiency.
  • In patients with history of serious hypersensitivity reactions, including anaphylaxis, to KRYSTEXXA or any of its components.

WARNINGS AND PRECAUTIONS

Gout Flares: An increase in gout flares is frequently observed upon initiation of anti-hyperuricemic therapy, including KRYSTEXXA. Gout flare prophylaxis with a non-steroidal anti-inflammatory drug (NSAID) or colchicine is recommended starting at least 1 week before initiation of KRYSTEXXA therapy and lasting at least 6 months, unless medically contraindicated or not tolerated.

Congestive Heart Failure: KRYSTEXXA has not been formally studied in patients with congestive heart failure, but some patients in the pre-marketing placebo-controlled clinical trials experienced exacerbation. Exercise caution in patients who have congestive heart failure and monitor patients closely following infusion.

ADVERSE REACTIONS

The most commonly reported adverse reactions (≥5%) are:

KRYSTEXXA co-administration with methotrexate trial:

KRYSTEXXA with methotrexate: gout flares, arthralgia, COVID-19, nausea, and fatigue; KRYSTEXXA alone: gout flares, arthralgia, COVID-19, nausea, fatigue, infusion reaction, pain in extremity, hypertension, and vomiting.

KRYSTEXXA pre-marketing placebo-controlled trials:

gout flares, infusion reactions, nausea, contusion or ecchymosis, nasopharyngitis, constipation, chest pain, anaphylaxis, and vomiting.

INDICATION

KRYSTEXXA® (pegloticase) is indicated for the treatment of chronic gout in adult patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.

Limitations of Use: KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.

Please see Full Prescribing Information, including Boxed Warning.

  • KRYSTEXXA (pegloticase) [prescribing information] Horizon.
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  • Zuo T, et al. BMC Cardiovascular Disorders. 2016;16:2.
  • Vincent ZL, et al. J Rheumatol. 2017;44:368-373.
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  • Aung T, et al. Patient Prefer Adherence. 2017;11:795-800.
  • Nickeleit V, et al. Nephrol Dial Transplant. 1997;12:1832-1838.
  • Klauser AS, et al. JAMA Cardiol. 2019;4:1019-1028.
  • Khanna PP, et al. J Clin Med. 2020;9:3204.
  • Pecherstorfer C, et al. ACR Open Rheumatol. 2020;2:565-572.
  • Ao J, et al. Clin Exp Ophthalmol. 2017;45:73-80.
  • Sundy JS, et al. JAMA. 2011;306:711-720.
  • Botson J, et al. J Rheumatol. 2021;48:767-774.